The study, called the Surfactant, Positive Pressure and Oxygenation Randomized Trial, has put UAB under the microscope during the past few months after the Office for Human Research Protections claimed that the university didn't properly inform parents of the study's health risks.

But the NEJM letter published on June 26 maintained that holes still existed in UAB's consent process.

"The aims of the SUPPORT study were commendable, and the study addressed important clinical issues," the letter said. "Nevertheless, however complex and important a study may be, the consent process must be clear enough to enable informed decision making."

The letter, signed by medical, research and law faculty, quoted federal requirements for informed consent, saying that a study must explain its purpose, describe the procedures to be followed, identify experimental procedures, describe foreseeable risks to the subject and disclose alternative courses of treatment that might be advantageous to the subject.

The letter conceded the study was complicated, but said the consent forms were still inadequate.

"They failed in each of the elements described above," the letter said, referring to the informed consent requirements. "Although the consent forms varied in content among the institutions at which the study was conducted, none specifically mentioned death as a possible risk of the oxygen interventions in the study."

The UAB study took place from 2004 to 2009 and enrolled 1,300 babies at 23 nationwide hospitals. The study aimed to determine which oxygen levels administered to the babies lowered chances of blindness without increasing risks such as death or brain damage.

In the study's defense, Richard Marchase, UAB's vice president for research and economic development, has told us that the higher mortality rate caused by the lower oxygen saturation levels was an unexpected finding that could not be communicated as a potential risk. He also said just 1 percent of the babies diagnosed with a condition that can lead to vision loss experienced blindness in one or two eyes.

Since a lawsuit targeting the study was filed in April, UAB officials have declined to comment on the matter, citing pending litigation.

"Of course, the outcomes were not known ahead of time, but a potential differential in the risks that were being tracked ... was reasonably foreseeable, since determining differential risk was the very purpose of the study," the letter said.

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